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CBT4CBT for Women in Residential Treatment for Substance Use Disorders

Primary Purpose

Substance Use Disorders, Drug Abuse, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment as Usual (TAU)
TAU+CBT4CBT
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years of age
  • Female
  • Meet DSM-5 criteria for a SUD (current)
  • Own a smartphone
  • Can return to facility for the 4 and 12-week follow-up visits.

Exclusion Criteria:

  • Pregnant
  • Cognitive or psychiatric impairment
  • Language barriers that preclude informed consent

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual (TAU)

TAU+CBT4CBT

Arm Description

Standard of care

TAU with access to the CBT4CBT program

Outcomes

Primary Outcome Measures

Any Relapse
Percent of participants experiencing any relapse (yes/no), defined as any substance use (alcohol or other drugs) by self-report (smartphone or in person) and/or urine drug toxicology or Breathalyzer during 12-week follow-up period.
Days of Use
Number of days of any substance use in 12 weeks post-discharge.

Secondary Outcome Measures

Time to Relapse:
Number of days post discharge to first use of any substance.

Full Information

First Posted
September 18, 2018
Last Updated
February 3, 2020
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03678051
Brief Title
CBT4CBT for Women in Residential Treatment for Substance Use Disorders
Official Title
A Randomized Trial of CBT4CBT for Women in Residential Treatment for Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This project examines computer-delivered cognitive-behavioral intervention (CBT4CBT) as an adjunct to residential treatment for women with substance use disorders (SUD). The project will conduct a 2-arm randomized clinical trial (RCT) comparing post-discharge relapse rates for treatment as usual (TAU) with access to the CBT4CBT program vs. TAU in a residential sample of women with SUDs.
Detailed Description
Women with substance use disorders face unique barriers to substance use treatment, and as a result, are less likely to seek treatment for substance use than their male counterparts. Women's residential treatment settings have been shown to have higher rates of treatment completion and better outcomes; however, relapse rates for substance use are high, with estimates ranging from 40-60%. Cognitive behavioral therapy (CBT) has been identified as an evidence-based treatment known to improve relapse rates by teaching clients how to recognize and respond to their cues for substance use. Women may particularly benefit from CBT, as their relapse risk factors include depression, interpersonal stress, and relationship conflict. Despite the effectiveness of CBT, its dissemination is hindered due to limited availability of trained clinicians, cost, and limited resources. Computer-based training for cognitive behavioral therapy (CBT4CBT) offers an opportunity to improve the quality and reach of treatment services that is both feasible and cost-effective. Studies to date have demonstrated the utility of CBT4CBT in outpatient settings; however, it has not yet been evaluated as an adjunct to residential treatment for SUDs. The specific aims are to: 1) Examine feasibility for use of CBT4CBT in a residential treatment program for women with SUDs; 2) Conduct a small RCT comparing TAU with access to the CBT4CBT program (CBT4CBT; intervention) vs. treatment as usual (TAU; control) using relapse rates and days of use as primary treatment outcomes; 3) Exploratory analyses will identify other correlates (e.g., coping strategies, depression) of relapse at 4 and 12 weeks post-discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Drug Abuse, Drug Addiction, Substance Abuse, Drug Use Disorders, Drug Dependence, Substance Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Standard of care
Arm Title
TAU+CBT4CBT
Arm Type
Experimental
Arm Description
TAU with access to the CBT4CBT program
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Standard of care residential treatment
Intervention Type
Behavioral
Intervention Name(s)
TAU+CBT4CBT
Intervention Description
45-minute web-based modules covering core concepts to substance use treatment. The information is presented via graphics and voiceovers and key concepts are illustrated with brief videos depicting the material. Participants will be scheduled for a minimum of two sessions/week over the 3.5 weeks post-randomization (7 modules). These seven sessions will provide protected time to access the interventions, but the women will be able to access the modules and complete homework as much as they wish.
Primary Outcome Measure Information:
Title
Any Relapse
Description
Percent of participants experiencing any relapse (yes/no), defined as any substance use (alcohol or other drugs) by self-report (smartphone or in person) and/or urine drug toxicology or Breathalyzer during 12-week follow-up period.
Time Frame
12-week follow-up period
Title
Days of Use
Description
Number of days of any substance use in 12 weeks post-discharge.
Time Frame
12-week follow-up period
Secondary Outcome Measure Information:
Title
Time to Relapse:
Description
Number of days post discharge to first use of any substance.
Time Frame
12-week follow-up period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years of age Female Meet DSM-5 criteria for a SUD (current) Own a smartphone Can return to facility for the 4 and 12-week follow-up visits. Exclusion Criteria: Pregnant Cognitive or psychiatric impairment Language barriers that preclude informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dace Svikis Pickens, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CBT4CBT for Women in Residential Treatment for Substance Use Disorders

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